Milnacipran hydrochloride
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]
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Black Box Warning
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WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
See full prescribing information for complete Boxed Warning.
Milnacipran hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of such drugs in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on Savella should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Savella is not approved for use in the treatment of major depressive disorder. Savella is not approved for use in pediatric patients
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Overview
Milnacipran hydrochloride is a serotonin/norepinephrine reuptake inhibitor that is FDA approved for the treatment of fibromyalgia. There is a Black Box Warning for this drug as shown here. Common adverse reactions include nausea, headache, constipation, dizziness, insomnia, hot flush, hyperhidrosis, vomiting, palpitations, heart rate increased, dry mouth, and hypertension.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Milnacipran hydrochloride indicated for the management of fibromyalgia.
- Dosage:
- Administer Savella in two divided doses per day.
- Based on efficacy and tolerability, dosing may be titrated according to the following schedule:
- Day 1: 12.5 mg once
- Days 2-3: 25 mg/day (12.5 mg twice daily)
- Days 4-7: 50 mg/day (25 mg twice daily)
- After Day 7: 100 mg/day (50 mg twice daily)
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Milnacipran hydrochloride in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Milnacipran hydrochloride in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Milnacipran hydrochloride FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Milnacipran hydrochloride in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Milnacipran hydrochloride in pediatric patients.
Contraindications
There is limited information regarding Milnacipran hydrochloride Contraindications in the drug label.
Warnings
|
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
See full prescribing information for complete Boxed Warning.
Milnacipran hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of such drugs in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on Savella should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Savella is not approved for use in the treatment of major depressive disorder. Savella is not approved for use in pediatric patients
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There is limited information regarding Milnacipran hydrochloride Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Milnacipran hydrochloride Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Milnacipran hydrochloride Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Milnacipran hydrochloride Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Milnacipran hydrochloride in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Milnacipran hydrochloride in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Milnacipran hydrochloride during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Milnacipran hydrochloride in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Milnacipran hydrochloride in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Milnacipran hydrochloride in geriatric settings.
Gender
There is no FDA guidance on the use of Milnacipran hydrochloride with respect to specific gender populations.
Race
There is no FDA guidance on the use of Milnacipran hydrochloride with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Milnacipran hydrochloride in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Milnacipran hydrochloride in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Milnacipran hydrochloride in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Milnacipran hydrochloride in patients who are immunocompromised.
Administration and Monitoring
Administration
Oral
Monitoring
There is limited information regarding Milnacipran hydrochloride Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Milnacipran hydrochloride and IV administrations.
Overdosage
There is limited information regarding Milnacipran hydrochloride overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Milnacipran hydrochloride Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Milnacipran hydrochloride Mechanism of Action in the drug label.
Structure
There is limited information regarding Milnacipran hydrochloride Structure in the drug label.
Pharmacodynamics
There is limited information regarding Milnacipran hydrochloride Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Milnacipran hydrochloride Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Milnacipran hydrochloride Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Milnacipran hydrochloride Clinical Studies in the drug label.
How Supplied
There is limited information regarding Milnacipran hydrochloride How Supplied in the drug label.
Storage
There is limited information regarding Milnacipran hydrochloride Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Milnacipran hydrochloride Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Milnacipran hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Milnacipran hydrochloride Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Milnacipran hydrochloride Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.